Z-3258-2011

ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave...

Name: Z-3258-2011 ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave...
Creator: Angiodynamics, Inc.
Published: 2011-04-04
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2011-04-04 / Terminated / root cause: design

FDA source

Angiodynamics, Inc. began a recall of ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control... on 2011-04-04. The reason FDA records is "Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-3258-2011
Status: Terminated
Initiated: 2011-04-04
Posted: 2011-09-23
Terminated: 2016-01-29
Recalling firm: Boston Scientific Corporation
Product: ANGIODYNAMICS NANOKNIFE IRE GENERATOR, Catalog/REF No. 20300101, ANGIODYNAMICS, 603 Queensbury Ave., Queensbury, NY 12804 Intended to remove tissue and control bleeding by the use of high- frequency electrical current (surgical ablation of soft tissue).
Product code: OAB Low Energy Direct Current Thermal Ablation System
Reason for recall: Some units of Nanoknife have the potential to deliver a shortened pulse width without indicating an error. The affected units contain a "GOMe" circuit board which may cause the generator to drift from the calibration points set at the time of manufacture.
Root cause tag: design
FDA root cause: Component design/selection
Action: AngioDynamics, Inc. sent a "NOTIFICATION OF MEDICAL DEVICE CORRECTION" letter dated April 4, 2011 to all affected customers. The letter describes the product, problem, and action to be taken. The letter instructs customers to review the measurement graphs (displayed on generator) after each delivery of energy, and to contact AngioDynamics Customer Service at 1-800-772-6446 if shortened pulses are detected. Contact your local sales representative or call Customer Service for any additional concerns or questions regarding this notice.
Quantity in commerce: 21 units
Distribution: Worldwide Distribution--USA (nationwide) and the countries of Australia, Germany, Israel, Italy, and Spain,
Product codes and lots: Batch/Serial Numbers: 00120508, 00090508, 00880909, 00371008, 00670709, 00850909, 00890909, 00780709, 00220708, 00300708, 00951009, 00900909, 00800709, 00260708, 00650709, 00690709, 00920909, 00930909, 00770709, 00130508, 01001009.

Product code OAB

K080376Class IIOncobionic SystemOncobionic Incorporated / cleared 2008-04-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)